"That letter, in my mind, is part of the conversation where you'll see a dialogue between the company and the agency, and they can always, after that letter, ask for the more detailed review,"
"But that's part of the process. That's a conversation."
"This type of chaotic decision-making is the opposite of what the regulator should be doing to regulate medicines in the U.S.,"
"The industry depends on clear, transparent rules that are applied consistently in order to make the long-term investments that benefit Americans,"
The FDA initially refused to file Moderna's application for the first mRNA flu shot, then reversed course and agreed to review the application with some changes. FDA Commissioner Marty Makary described the refuse-to-file letter as part of a dialogue between the company and the agency that can lead to a more detailed review. Health economist Rena Conti criticized the agency's actions as chaotic and inconsistent. Moderna applied mRNA technology used for COVID-19 to develop a flu vaccine and reports total investment over a billion dollars, including up to $750 million from Blackstone. The FDA's initial refusal cited absence of a comparison to a high-dose flu vaccine for older adults. Moderna says the agency had agreed to the study design 18 months earlier. According to a company statement, Moderna included data from a separate trial.
Read at www.npr.org
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